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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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MEDTRONIC MEXICO PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number PCE025120130
Device Problem Burst Container or Vessel (1074)
Patient Problem Fistula (1862)
Event Date 06/28/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a pacific plus pta balloon during procedure to treat a little calcified lesion in the left proximal anterior tibial artery (ata) with 50% stenosis. The vessel was little tortuous. The vessel diameter and lesion length were 3mm and 10mm respectively. The device was prepped per ifu with no issues identified. A non-medtronic device was used to inflate balloon. During balloon inflation a radial burst occurred at 8atm. All balloon fragments were retrieved. It was reported that after the guide wire crossed the lesion, the balloon was used to dilate the blood vessel. When dilated for the third time, the balloon burst within the rated burst pressure range, leading to arteriovenous fistula for patient's blood vessel.
 
Manufacturer Narrative
Additional information: all balloon fragments were retrieved within the sheath. The procedure was completed with dilations from other balloons, where there was no effect on the fistula. No further treatment was given and none are planned in the future for fistula. No further patient injury reported. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePACIFIC PLUS
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key10218896
MDR Text Key197179131
Report Number9612164-2020-02387
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K123358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPCE025120130
Device Lot Number218519818
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/01/2020 Patient Sequence Number: 1
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